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Cogent Biosciences
Cogent Biosciences makes bezuclastinib, a pill that blocks a mutated protein called KIT. It is being tested in a rare gut tumour called GIST and in systemic mastocytosis, a disease of overactive immune cells.
Overview
Cogent Biosciences is a Waltham, Massachusetts and Boulder, Colorado company developing precision therapies for genetically defined diseases. Its lead candidate, bezuclastinib, is a selective tyrosine kinase inhibitor of KIT D816V and other KIT mutations. In November 2025 it reported positive top-line SUMMIT results in non-advanced systemic mastocytosis (FDA Breakthrough Therapy designation; NDA planned for year-end 2025) and awaited the phase 3 PEAK trial of bezuclastinib plus sunitinib in second-line gastrointestinal stromal tumours (GIST) and the registration-directed APEX trial in advanced systemic mastocytosis. Preclinical programmes include a JAK2 V617F mutant-selective inhibitor, a pan-KRAS(ON/OFF) inhibitor, and selective ErbB2 (HER2), PI3K-alpha and FGFR2 inhibitors. Cogent (formerly Unum Therapeutics) trades on Nasdaq as COGT and reported about 430 million US dollars pro forma cash in November 2025.
Headquarters
Waltham, MA, US
Scorecard
All companies#281of 1244 companies, score 16
- phase 3 +3
- phase 1/2 +1
- targets +6
- modalities +2
- registry trials +4
0 approved, 1 in phase 3, 1 earlier, 3 targets, 5 registry studies. Formula on the scorecards page.
Type
Biotech · COGT
Stage
Public
Website
Phase 3small molecule
Bezuclastinib is an experimental small-molecule drug from Cogent Biosciences in phase 3 trials for gastrointestinal stromal tumour, aimed at KIT and MET.
Phase 2small molecule (structure undisclosed or not yet in PubChem)
CGT4859 is an experimental small-molecule drug from Cogent Biosciences in phase 2 trials for biliary tract cancer, aimed at FGFR2.
Notes
top- PEAK and APEX results (expected November and December 2025) were not verified.
Similar pages
- CancerIndolent and smouldering systemic mastocytosis
Shares (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis, Bezuclastinib, KIT, Small-molecule kinase inhibitors.
- CancerAdvanced systemic mastocytosis (aggressive SM, SM with an associated haematological neoplasm, mast cell leukaemia)
Shares (Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis, Bezuclastinib, KIT, Small-molecule kinase inhibitors.
- Key paperComprehensive molecular characterization of gallbladder carcinoma and potential targets for intervention
Shares FGFR2, PIK3CA / PI3K-alpha, HER2, KRAS.
- TrialSSGXVIII/AIO (adjuvant imatinib in GIST)
Shares KIT, Sarcomas (soft tissue, bone, GIST), Small-molecule kinase inhibitors.
- PersonGeorge D. Demetri
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- TrialINVICTUS
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- CompanyRelay Therapeutics
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- TermHallmark: sustaining proliferative signalling
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cancers
fronts
technologies
targets
drugs
Phase 3small molecule
Phase 2small molecule (structure undisclosed or not yet in PubChem)
trials
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic MastocytosisA Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors